BY Timothy S. Donahue

Top Takeaways:

• One form: FDA combined separate registration and product-listing forms into a redesigned Form 3741.
• All categories: The form now covers cigarettes, vapor products, smokeless tobacco, heated tobacco and oral nicotine products.
• Less repetition: Manufacturers can update specific information without resubmitting unchanged sections.

There’s one less form for tobacco manufacturers to worry about.

The U.S. Food and Drug Administration has consolidated two tobacco establishment registration and product listing forms into a single Form FDA 3741 that covers all regulated tobacco product categories.

The redesigned form, launched on Sept. 28, replaces the previous Form FDA 3741 for products such as cigarettes and smokeless tobacco, and Form FDA 3741a for deemed tobacco products such as e-cigarettes and nicotine pouches.

The new Form 3741 covers cigarettes, e-cigarettes, smokeless tobacco, heated tobacco products, and oral nicotine products, including nicotine pouches.

FDA said the change eliminates the need for manufacturers to determine which of the two forms applies to their products or to submit separately when their portfolios span different tobacco categories.

The redesigned form also includes a submission checklist that directs users to the sections relevant to their filing. Manufacturers updating existing registrations can modify specific information without resubmitting sections that have not changed.

FDA also introduced Form FDA 3741b, a spreadsheet that the agency encourages manufacturers to use for initial product-list submissions or for adding new products to existing lists.

The paperwork changed, but the deadlines didn’t. Domestic tobacco product manufacturers must register their establishments with the FDA annually by Dec. 31.

Those manufacturers must also update their product listings twice annually, on June 30 and Dec. 31, when specified changes occur.

The FDA is encouraging manufacturers to submit the redesigned form electronically via its Tobacco Registration and Product Listing Module Next Generation (TRLM NG).

Manufacturers unable to use the electronic system can submit a paper Form 3741 to the Center for Tobacco Products’ Document Control Center. Form 3741b can also be printed or saved to a USB flash drive or DVD and then mailed to the FDA.

Companies don’t need to start over.

Existing registrations and product listings remain in TRLM NG, and manufacturers are not required to resubmit their complete registrations due to the change. Instead, existing users will receive prompts in the system to update the information needed to align their registrations and product listings with the redesigned form.

The previous versions of Forms FDA 3741 and 3741a have been retired.

The consolidation is another recent change to FDA’s tobacco submission infrastructure. In July, the agency added features to the CTP Portal NextGen for premarket tobacco product applications and substantial equivalence reports, and announced plans to phase out eSubmitter for those submissions after Nov. 14.